FDA.reportPublic FDA data

Anticavity

Product NDC
30142-004
11-digit product format
301420004
Labeler code
30142
Product ID
30142-004_4bd01ecc-3161-9e25-e063-6294a90a6a20
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
RINSE
Route
ORAL
Labeler
The Kroger Co.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-18
Substance
SODIUM FLUORIDE
Active strength
.2 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Anticavity
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
240698Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
27a98b64-8369-4f3d-b487-d7ce98abc69fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-004-77Anticavity500 mL in 1 BOTTLE, PLASTICRINSE50017

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]1
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]1
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955ANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]1
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]1
SORBITOLINACTIVE INGREDIENT506T60A25RANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]1
WATERINACTIVE INGREDIENT059QF0KO0RANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-004ANTICAVITY (SODIUM FLUORIDE) RINSE [KROGER CO]15Current NDC, Legacy NDC, 1 package rows20250308_27a98b64-8369-4f3d-b487-d7ce98abc69f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 39 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hismile Miffy Sweet Apple Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHismile Pty Ltd2ba2318e-7a58-7b68-e063-6394a90ae7842025-03-13WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint Anticavity FluorideSODIUM FLUORIDEKenvue Brands LLCed15e0b9-00c9-0df1-e053-2a95a90a42c02025-02-28WarningsExact identifier
application number: M021
WHITE GLO BIO-ENZYMESODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCf894a841-0df7-470d-8fc2-c9d6ba0edf992025-02-26WarningsExact identifier
application number: M021
WHITE GLO MICELLARSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC16be06ba-330d-46b8-ba4e-5d732642ee262025-02-26WarningsExact identifier
application number: M021
WHITE GLO PROFESSIONAL CHOICESODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC13314c9a-de93-4f54-b703-b5cebdf1e6aa2025-02-26WarningsExact identifier
application number: M021
WHITE GLO CHARCOALSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCa14bb838-f07a-3a6f-e053-2995a90a535d2025-02-26WarningsExact identifier
application number: M021
White Glo Maximum White CharcoalSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f64d2-969f-7ac1-e053-2995a90a627b2025-02-26WarningsExact identifier
application number: M021
White Glo Instant WhiteSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f0f8f-46f0-b4e6-e053-2a95a90af6c62025-02-26WarningsExact identifier
application number: M021
White Glo Instant White Blue Foam Optical Enhancers Fluoride Anticavity Value 2 pack and ToothbrushSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC7c15eedb-d4ca-4fc1-8a1e-6f9cad0cc1262025-02-26WarningsExact identifier
application number: M021
White Glo Mouthwash ProtectionSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f0f8f-46f1-b4e6-e053-2a95a90af6c62025-02-26WarningsExact identifier
application number: M021
White Glo Professional White AntiCavitySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC1fb04108-31b3-43dd-9509-bfa8461135162025-02-26WarningsExact identifier
application number: M021
White Glo Activated Charcoal Twin PackSODIUM FLUORIDEWHITE GLO USA INC6adaca4f-5599-41e0-9215-c7ee5c1dc3722025-02-26WarningsExact identifier
application number: M021
White Glo Professional Choice Twin PackSODIUM FLUORIDEWHITE GLO USA INC0c913e38-e655-7208-e063-6294a90a58c92025-02-26WarningsExact identifier
application number: M021
White Glo Advantage Anticavity Fluoride PurpleSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCb25aa35b-98ce-4605-a7b1-8c2fe476e1a82025-02-26WarningsExact identifier
application number: M021
White Glo Coffee and Tea Stain Remover Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCd69387f9-03b8-4551-a814-20606500af282025-02-26WarningsExact identifier
application number: M021
White Glo Advantage Anticavity Professional WhiteningSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC164c3e87-74e5-4128-9bd7-60e162e589842025-02-26WarningsExact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse Mint ShieldSODIUM FLUORIDEKenvue Brands LLC2e01b69a-b8f7-f2b9-e063-6294a90af3882025-02-13WarningsExact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse Bubble BlastSODIUM FLUORIDEKenvue Brands LLC2e021015-bb43-482b-e063-6294a90a69022025-02-13WarningsExact identifier
application number: M021
ZONSEN Gel FluorideGEL FLUORIDE TOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c1e40c9-8314-46ac-e063-6294a90a84ba2025-02-11WarningsExact identifier
application number: M021
ZONSEN Toothpaste,whiteTOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c3349bf-710b-fb84-e063-6394a90a3cc72025-02-11WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN27a98b64-8369-4f3d-b487-d7ce98abc69f17
240698sodium fluoride 0.5 MG/ML MouthwashSCD27a98b64-8369-4f3d-b487-d7ce98abc69f17
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY27a98b64-8369-4f3d-b487-d7ce98abc69f17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-004-7730142000477500 mL in 1 BOTTLE, PLASTIC (30142-004-77) 500 ml2013-01-180000-00-00NoNoCurrent